FDA 510(k)

4CIS® Chiron Spinal Fixation System

Número K: K190471 · 2019-07-24

Data da decisão2019-07-24

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

4CIS® Chiron Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2019-07-24 under 510(k) number K190471. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 4CIS® Chiron Spinal Fixation System?

4CIS® Chiron Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2019-07-24. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K190471.

When did 4CIS® Chiron Spinal Fixation System receive FDA 510(k) clearance?

4CIS® Chiron Spinal Fixation System received FDA 510(k) clearance on 2019-07-24, under 510(k) number K190471.

Who is the listed applicant for 4CIS® Chiron Spinal Fixation System?

The FDA 510(k) record lists Solco Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS® Chiron Spinal Fixation System?

The FDA product code for 4CIS® Chiron Spinal Fixation System is NKB.

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Outros registros que listam Solco Biomedical Co., Ltd. como candidato(a)

K2316554CIS® Chiron Spinal Fixation System K203233SISTEMA DE FIXAÇÃO ESPINAL 4CIS Chiron K192044CAGE DE ACIF DE PEEK 4CIS Marlin K190563CAGE DE PLIF DE PEEK 4CIS, CAGE DE PLIF DE PEEK Pebble Beach 4CIS, CAGE DE TLIF DE PEEK Torrey Pines 4CIS, CAGE DE DLIF DE PEEK Dunes 4CIS, CAGE DE ALIF DE PEEK Augusta 4CIS K1824894CIS® Pinehurst Anterior Cervical Plate system K1624024CIS® Marlin ACIF Cage System

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Fonte oficial

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